title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Intervention groups | GROUP B | The intervention was one of the following three treatment methods:Group A: Muscular injection of Diphereline 11.25 mg (produced by Ipsen France) in three-month intervals.Group B: Muscular injection of Microrelin 11.25 mg (produced by Homa Pharmed Company) in three-month intervals.Group C: Muscular injection of Microrel... | PMC10638790 | |
Outcomes | The outcomes of the study consisted of serum estradiol and FSH levels and score of menopause symptoms every three months. | PMC10638790 | ||
Blinding description | Blindness, ’ | BLINDNESS | In this study, a trained nurse in the research team recorded demographic and clinical characteristics, outcome results, and randomized allocation to different groups. In the two groups receiving three-month injections, patients and observers (oncologist and nurse) were blinded to the administered drug. Blindness was no... | PMC10638790 |
Sample size | During the study, we tried to minimize loss to follow-up by close monitoring of the patients. The primary outcome under investigation was changes in serum estradiol and FSH levels over one year. In a similar study [ | PMC10638790 | ||
Statistical analysis | MRS | Descriptive statistics were used to analyze the demographic and clinical characteristics of all participants in the three treatment groups. The frequency distribution of variables was compared among the groups to ensure proper randomization. The outcome variables were FSH and Estradiol levels and MRS scores which they ... | PMC10638790 | |
Results | MCI | INTERACTION, IDC, MRS, INVASIVE DUCTAL CARCINOMA | In this study, we performed two interim analyses with 30% and 50% of the anticipated sample size. Both analyses confirmed the non-inferiority of drugs B and C compared to A. So, we achieved a final analysis on 133 patients of group A (n = 43), group B (n = 47), and group C (n = 43). A few participants were excluded as ... | PMC10638790 |
Discussion | breast cancers, breast cancer, cancer, cognitive problems, prostate, uterine, and ovarian cancers, depression, vaginal dryness | PREMATURE PUBERTY, STILL, ABNORMAL UTERINE BLEEDING, BREAST CANCER, SIDE EFFECT, CANCER, DRUG SIDE EFFECTS, REGRESSION, DISEASES, COMPLICATIONS | Given the rising trend of breast cancer in the world and in Iran and the ensuing widespread use of GnRH agonists by these patients, physicians and patients must have access to products with the least side effects and the greatest effectiveness. This non-inferiority RCT aimed to compare the effectiveness of two injectab... | PMC10638790 |
Acknowledgements | Breast Cancer | BREAST CANCER | The researchers at the Breast Cancer Research Center appreciate the financial support of Homa Pharmed Company for providing the drug for all studied patients. | PMC10638790 |
Authors’ contributions | Safa Najafi: conceptualization, methodology, investigation, supervision, writing (original draft preparation, review and editing). Maryam Ansari: managing project, data collection, writing (original draft preparation). Zahra Omidi: investigation, data collection, writing (original draft preparation, review and editing)... | PMC10638790 | ||
Funding | A grant from Homa pharmed Company funded the original research. | PMC10638790 | ||
Data Availability | The datasets used and analyzed during the current study are available from the corresponding author on reasonable request. | PMC10638790 | ||
Declarations | PMC10638790 | |||
Ethics approval and consent to participate | Breast Cancer | BREAST CANCER | This study was conducted in compliance with the principles of the Declaration of Helsinki. This research was approved by the Ethics Committee of the Breast Cancer Research Center and registered with the code: IR.ACECR.IBCRC.REC.1397.003. All the participants signed written informed consent forms prior to participation ... | PMC10638790 |
Consent for publication | Not Applicable. | PMC10638790 | ||
Competing interests | The authors have no conflicts of interest. | PMC10638790 | ||
Trial availability | This study was registered at the Iranian Registry of Clinical Trials (IRCT) on | PMC10638790 | ||
Abbreviations | Luteinizing hormone-releasing hormone agonistEstrogen receptorprogesterone receptorFollicle stimulating hormoneLuteinizing hormoneGonadotropin releasing hormone | PMC10638790 | ||
References | PMC10638790 | |||
1. Introduction | fatigue, anxiety, gastrointestinal problems, cancer, depression, Cancer | CANCER, PMR, CANCER | Cancer patients receiving chemotherapeutic treatments routinely suffer from distressing physical symptoms such as gastrointestinal problems, fatigue, neurological effects [Recently, non-pharmacological interventions have been commonly suggested to minimize the adverse psychological effects during cancer treatment. Many... | PMC10624313 |
2. Methods | PMC10624313 | |||
2.1. Design | MAY | A 2-arm, assessor-blinded pilot randomized controlled trial was conducted at at a chemotherapy unit in an oncology hospital, Hanoi, Vietnam, from March to May 2022. | PMC10624313 | |
2.2. Participants | breast or gynaecological cancer | The inclusion criteria were: (1) women with breast or gynaecological cancer aged 18 years or older; (2) receiving chemotherapy once every three weeks and have at least three chemotherapy cycles left; (3) Have Karnofsky score ≥ 80 [ | PMC10624313 | |
2.3. Study sample | Convenience sampling was used to recruit the participants. The sample size planning followed a rule of thumb for determining an appropriate sample size in which the outcome is a continuous measurement. Julious [ | PMC10624313 | ||
2.4. Randomization and allocation concealment | Blocked randomization procedures with a block size of 8 in 1:1 allocation ratio was performed by an independent researcher who did not involve any steps of the intervention program. A random group allocation list was generated by using the online randomizer ( | PMC10624313 | ||
2.5. The combined intervention PMR and MI procedure | PMR | The participants in the intervention group were required to wear loose-fitting, soft clothes, and entered a private, quiet, dimmed light room to receive a face-to-face training session of PMR combined with MI. The training session was performed by the principal investigator (PI), who is certified in PMR and MI. After b... | PMC10624313 | |
2.6. Outcome measures and instruments | Anxiety, cancer, depression, Depression, Cancer | CANCER, RECRUITMENT, CANCER | The recruitment rate, eligibility, consent rate, refusal rate, reasons for refusal, and attrition rate were recorded to assess the feasibility. Individual face-to-face semi-structured interviews were conducted with ten participants in the intervention group to review the acceptability of the intervention. The interview... | PMC10624313 |
2.7. Data collection | The baseline data was collected using the demographic sheet, DASS, and FACT-G by an outcome assessor. The outcome assessor was blinded to the study groups to collect data and did not involve any study steps. DASS and FACT-G were re-evaluated after finishing three weeks of self-practice intervention (T1) and three weeks... | PMC10624313 | ||
Time points for data collection. | PMC10624313 | |||
2.8. Data analysis | Statistical analyses were performed using SPSS version 25. Appropriate descriptive statistics, such as mean, standard deviation, frequency and percentage, were used to summarize and present the baseline characteristics of the participants and the outcome measures across study time points. The preliminary effects of the... | PMC10624313 | ||
2.9. Ethical approval | The pilot study was conducted in accordance with the Declaration of Helsinki and written informed consent was obtained from all participants prior to enrollment. The study was approved by The Joint Chinese University of Hong Kong—New Territories East Cluster Clinical Research Ethics Committee (No. 2021.725), the Ethics... | PMC10624313 | ||
3. Result | PMC10624313 | |||
3.1. Feasibility of the study | The whole data collection process was done from 8One participant dropped out (4.2%) at T1 because she changed to another hospital. Three participants dropped out at T2 (12.5%), including two participants in the intervention group due to changing the chemotherapy schedule and feeling exhausted and one in the control gro... | PMC10624313 | ||
The Consolidated Standards of Reporting Trial (CONSORT) flow diagram. | PMC10624313 | |||
3.2. Preliminary effects of MI combined with PMR on outcome measures | PMC10624313 | |||
3.2.1 Participants’ demographic and clinical characteristics | The mean age of the participants was 52.3 years. Nearly half of the participants (45.8%) obtained a bachelor’s or higher degree. The majority of participants did not have a religious belief (83.3%). More than half of the participants were current workers (58.3%), living in a city area (66.7%), and married (62.5%). The ... | PMC10624313 | ||
Baseline demographic information of the participants by group assignment. | cancer, DongBreast cancer | CANCER, MUSCLE RELAXATION | MCP: Music intervention combined with progressive muscle relaxation group, SD: standard deviation VND: Vietnam DongBreast cancer accounted for most of the participants (79.2%). Nearly half of participants were stage 4 cancer (45.8%). The mean time from diagnosis was 20.04 months. Half of the participants were treated w... | PMC10624313 |
Baseline clinical characteristics of the participants by group assignment. | MUSCLE RELAXATION | MCP: Music intervention combined with progressive muscle relaxation group, SD: Standard deviation. | PMC10624313 | |
Outcome measures across time between the groups. | Data are presented as mean (standard deviation) at time points.Abbreviations: T0, baseline; T1, 3 weeks from baseline; T2, 6 weeks from baseline, CI: Confidence Interval.# Small sample bias-corrected Hedges’g effect size which corresponds to the standardized mean difference of the mean changes at the underlying time po... | PMC10624313 | ||
3.3. The acceptability of the intervention | A total of ten participants completed the semi-structured interview, and two themes were generated regarding the acceptability of the intervention. The themes were: (1) Perceived beneficial effect on psychological and physical health and (2) Willing to keep practising in the future. | PMC10624313 | ||
Theme 1: Perceived beneficial effect on psychological and physical health | reduced nausea, vomiting, insomnia, pain | Most participants reported that they had better psychological and physical health after three weeks of self-practice at home. Participants reported feeling comfortable, relaxed, and calm.“Besides, some participants reported positive effects on physical health, such as reduced nausea, vomiting, pain, and insomnia.
| PMC10624313 | |
Theme 2: Willing to keep practising in the future | cancer | CANCER | The participants could feel the positive impacts on their health after the intervention. All the participants were willing to continue practising the intervention in the future and wanted to share the intervention with other cancer patients.
| PMC10624313 |
4. Discussion | depression, breast and gynaecological cancer, anxiety | PMR, RECRUITMENT | This pilot randomized controlled trial provided a novel way that combined MI with PMR to solve psychological issues commonly faced by breast and gynaecological cancer patients receiving chemotherapy. The pilot study results showed a promisingly high feasibility of the combined intervention and a potentially effective s... | PMC10624313 |
Strength and limitation | breast and gynaecological cancer | BLIND | A well-designed pilot randomized controlled trial was adopted in the current study with rigorous randomization allocation and blinded assessor. The intervention was developed basing the evidence and was evaluated by an expert panel. Multiple strategies were used to enhance the adherence rate of the participants at home... | PMC10624313 |
Conclusion | depression, breast and gynaecological cancer, anxiety | MUSCLE RELAXATION | Music intervention combined with progressive muscle relaxation was feasible and acceptable to women with breast and gynaecological cancer undergoing chemotherapy. The combined intervention may help manage anxiety, depression and stress in the target population, however, insufficient power pilot study findings should be... | PMC10624313 |
Supporting information | PMC10624313 | |||
CONSORT 2010 checklist of information to include when reporting a randomised trial*. | (DOC)Click here for additional data file. | PMC10624313 | ||
Tensing instruction of 16 muscle groups. | (PDF)Click here for additional data file. | PMC10624313 | ||
Study protocol. | Debra Burns | ONCOLOGY | (DOCX)Click here for additional data file.The authors would like to acknowledge all staff in Chemotherapy Unit H5, International Cooperation & Scientific Research Unit, Hanoi Oncology hospital for their support during data collection. We would like to thank Dr. Thapa Chura Bahadur for his support in language editing. W... | PMC10624313 |
Background | BUP-XR (SUBLOCADE | PMC10693082 | ||
Methods | treatment-emergent adverse, OUD | SECONDARY | This was a secondary analysis of a randomized, double-blind, placebo-controlled study in which adults with moderate or severe OUD received monthly injections of BUP-XR (2 × 300-mg doses, then 4 × 100-mg or 300-mg maintenance doses) or placebo for 24 weeks. Abstinence was defined as opioid-negative urine drug screens co... | PMC10693082 |
Results | EVENTS | BUP-XR 100-mg and 300-mg maintenance doses were equally effective in non-injecting participants. However, in opioid-injecting participants, the 300-mg maintenance dose delivered clinically meaningful improvements over the 100-mg maintenance dose for treatment retention and opioid abstinence. Exposure–response analyses ... | PMC10693082 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12954-023-00906-7. | PMC10693082 | ||
Introduction | OUD, overdose | DISORDER | Opioid use disorder (OUD) and overdose from opioids remain at epidemic levels in the USA despite the availability of effective treatments [Medications for OUD, including buprenorphine, methadone, and naltrexone, have established clinical efficacy and represent the standard of care in clinical practice. However, only ap... | PMC10693082 |
Methods | PMC10693082 | |||
Study design | OI | SECONDARY | This was a secondary analysis of a randomized, double-blind, placebo-controlled study which enrolled treatment-seeking adults who met the Phase 3 study design. After screening, participants entered an open-label run-in phase of up to 2 weeks of treatment with buprenorphine/naloxone sublingual film (induction and stabil... | PMC10693082 |
Analyses | OI | The efficacy and safety analysis set were the same. Both were defined as participants who received at least 1 maintenance dose (third injection on week 9) of 300 mg or 100 mg of BUP-XR. The effects of BUP-XR maintenance dose (300 mg vs. 100 mg) on efficacy and safety outcomes were analyzed separately for OI and NIO. Ba... | PMC10693082 | |
Efficacy analyses | OI, psychiatric | DISORDER | Urine drug screens (UDS) and self-reports for opioid use were collected weekly; abstinence at a given week was defined as opioid-negative UDS combined with negative self-reports for opioids (Timeline Followback interviews) [Variables measured before randomization: age, gender, race (black vs. non-black), body mass inde... | PMC10693082 |
Pharmacokinetic analyses | BLOOD | Blood samples were collected to measure buprenorphine plasma concentrations at weekly visits, with additional samples collected 4 and 24 h after each BUP-XR injection. Buprenorphine plasma concentration was determined using a validated liquid chromatography and tandem mass spectrometric method with a lower limit of qua... | PMC10693082 | |
Exposure–response analyses | OI | Exposure–response relationships were evaluated for the OI and NIO populations separately. Buprenorphine plasma concentrations were categorized into bins, and the percentage of observations indicating abstinence (negative UDS and self-report) was calculated for each concentration bin and plotted against buprenorphine le... | PMC10693082 | |
Safety analyses | treatment-emergent adverse, OI, TEAEs | HEPATIC DISORDERS | Safety data were analyzed for both BUP-XR maintenance dose groups (100 mg and 300 mg) within OI and NIO separately using the safety analysis set (participants who received at least one maintenance dose). The percentage of participants (incidence proportion) reporting treatment-emergent adverse events (TEAEs) was summar... | PMC10693082 |
Results | PMC10693082 | |||
Discussion | OI, OUD | SECONDARY | Overall, no significant difference in the percentage of opioid abstinence was observed between the 100-mg and 300-mg maintenance doses in non-injecting opioid participants, suggesting that the two dosing regimens performed equally well in this population. Conversely, in opioid-injecting participants, the 300-mg mainten... | PMC10693082 |
Conclusions | OI, difficult-to-treat | The 100-mg maintenance dose is well tolerated and may achieve sufficient efficacy outcomes in most NIO. In OI—a high-risk and difficult-to-treat population—the benefit of BUP-XR 300-mg maintenance dose is clinically relevant and may reduce harm by improving abstinence and treatment retention. | PMC10693082 | |
Acknowledgements | Editorial support was provided by Claire Daniele, PhD, of SciPubSupport, LLC. | PMC10693082 | ||
Author contributions | CML | CML | BRH, CML, and YZ designed the analyses. CML and YZ analyzed the data. KLW participated in the collection of the data. All authors participated in the interpretation of the results, revised the various drafts of the manuscript, and approved the final version. | PMC10693082 |
Funding | Pain | This study was funded by Indivior, Inc. MKG’s effort was supported by the Gertrude Levin Endowed Chair in Addiction and Pain Biology. | PMC10693082 | |
Availability of data and materials | Data are available from the authors upon reasonable request. All requests for raw and analyzed data will be promptly reviewed by the sponsor delegate to verify whether it is subject to any confidentiality obligations. Patient-related data not included in the paper were generated as part of clinical trials and may be su... | PMC10693082 | ||
Declarations | PMC10693082 | |||
Ethics approval and consent to participate | This study was approved by the Quorum Review Institutional Review Board (IRB# 30013). | PMC10693082 | ||
Consent for publication | Not applicable. | PMC10693082 | ||
Competing interests | CML | EVENTS, CML | CML and YZ are employees of Indivior, Inc. BRH is a former employee of Indivior, Inc. and holds stock. MKG has received compensation for medical education events from Indivior, Inc., unrelated to this manuscript. KLW has received compensation for advisory committee work from Indivior, Inc., unrelated to this manuscript... | PMC10693082 |
References | PMC10693082 | |||
Background | cardio-renal | CELLULAR PROLIFERATION, TYPE 2 DIABETES | The insulin-like growth factors (IGF) play a crucial role in regulating cellular proliferation, apoptosis, and key metabolic pathways. The ratio of IGF-1 to IGF binding protein-3 (IGFBP-3) is an important factor in determining IGF-1 bioactivity. We sought to investigate the association of IGF-1 and IGFBP-3 with cardio-... | PMC10339517 |
Methods | renal/cardiovascular death, chronic kidney disease, cardio-renal | REGRESSION, EVENTS, TYPE 2 DIABETES, END-STAGE KIDNEY DISEASE | Samples were available from 2627 individuals with type 2 diabetes and chronic kidney disease that were randomized to receive canagliflozin or placebo and were followed up for incident cardio-renal events. Primary outcome was defined as a composite of end-stage kidney disease, doubling of the serum creatinine level, or ... | PMC10339517 |
Results | Elevated IGF-1 was associated with lower glomerular filtration rate at baseline. Treatment with canagliflozin did not significantly change IGF-1 and IGFBP-3 concentrations by 3 years (p-value > 0.05). In multivariable models, elevated IGF-1 (above vs below age-specific cutoffs) was associated with the primary composite... | PMC10339517 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12933-023-01916-2. | PMC10339517 | ||
Keywords | PMC10339517 | |||
Background | cardio-renal complications, obesity, type 2 diabetes mellitus, cardio-renal | OBESITY, TYPE 2 DIABETES, TYPE 2 DIABETES MELLITUS, COMPLICATIONS | Individuals with type 2 diabetes mellitus are at increased risk of cardio-renal complications. Within the altered hormonal milieu among those with type 2 diabetes are changes in the insulin growth factor axis; recent studies have examined the role of insulin growth factor-1 (IGF-1) in the risk for complications from ty... | PMC10339517 |
Methods | PMC10339517 | |||
Study design and patient population | heart failure, death, renal death, HF | HEART FAILURE, END-STAGE KIDNEY DISEASE | The trial design, baseline patient characteristics, and the main study results from the CREDENCE trial have been published previously [In this analysis, only those study participants with available plasma for analysis of IGF-1 and IGFBP-3 at baseline were included (N = 2627). Plasma samples were collected at baseline, ... | PMC10339517 |
Statistical analysis | REGRESSION, DIABETES MELLITUS | Biomarkers were log transformed because of their skewed distribution. Median (interquartile) and count (frequency) were used to present continuous and categorical variables. Kruskal–Wallis, ANOVA, and chi-square tests were used to compare the baseline characteristics of study population across IGF-1 quartiles, IGFBP-3,... | PMC10339517 | |
Discussion | CKD, kidney disease, cardio-renal disease, DKD, cardio-renal, diabetes | KIDNEY DISEASE, EVENTS, CELLULAR PROLIFERATION, TYPE 2 DIABETES, INSULIN SENSITIVITY, COMPLICATIONS, DIABETES | In this trial of patients with type 2 diabetes and CKD who were randomized to receive canagliflozin or placebo, we showed that baseline IGF-1 levels and IGF-1/IGFBP-3 ratio (but not IGFBP-3 concentrations) were associated with cardio-renal outcomes. Higher IGF-1 levels (for a given age) were associated with a greater r... | PMC10339517 |
Conclusion | DKD, cardio-renal disease, kidney disease, cardio-renal | TYPE 2 DIABETES | In conclusion, this study provides evidence that elevated IGF-1 levels or the ratio of IGF-1/IGFBP-3 is associated with a higher risk of kidney disease progression and all-cause mortality. Three years of therapy with canagliflozin failed to impact IGF-1 or IGFBP-3 levels. Nonetheless, the benefit of canagliflozin to re... | PMC10339517 |
Acknowledgements | Technical editorial assistance was provided by Kayla Smull, of Lumanity Communications Inc. and funded by Janssen Research & Development, LLC. | PMC10339517 | ||
Author contributions | JJ | JJ, RM, JB, MKH contributed to the conception or design of the work. RM and YL contributed to the acquisition, analysis, or interpretation of data for the work. RM and JJ drafted the manuscript. MKH, YY, NS, JB, CAP, MJ and HJLH critically revised the manuscript. All gave final approval and agree to be accountable for ... | PMC10339517 | |
Funding | The CREDENCE trial and this analysis were funded by Janssen Research & Development, LLC. Canagliflozin was developed by Janssen Research & Development, LLC, in collaboration with Mitsubishi Tanabe Pharma Corporation. Dr. Mohebi is supported by Barry Fellowship. Dr. Januzzi is supported by the Hutter Family Professorshi... | PMC10339517 | ||
Availability of data and materials | The data underlying this article cannot be shared publicly due to proprietary restrictions. | PMC10339517 | ||
Declarations | PMC10339517 | |||
Ethics approval and consent to participate | Local ethics committees approved all study procedures for the CREDENCE trial and subsequent analyses. Consent was obtained from all study participants. | PMC10339517 | ||
Consent for publication | Not applicable. | PMC10339517 | ||
Competing interests | HANSEN | Drs. Michael Hansen and Yshai Yavin are full-time employees of Janssen Research & Development, LLC. Dr. Januzzi is supported by the Hutter Family Professorship; is a Trustee of the American College of Cardiology; is a board member of Imbria Pharmaceuticals and a Director at Jana Care; has received grant support from Ab... | PMC10339517 | |
References | PMC10339517 | |||
Background | LRTIs, lower respiratory tract infections | LOWER RESPIRATORY TRACT INFECTIONS | Antibiotics are commonly prescribed for children with lower respiratory tract infections (LRTIs), fuelling antibiotic resistance, and there are few prognostic tools available to inform management. | PMC10664149 |
Aim | To externally validate an existing prognostic model (STARWAVe) to identify children at low risk of illness progression, and if model performance was limited to develop a new internally validated prognostic model. | PMC10664149 | ||
Design and setting | Prospective cohort study with a nested trial in a primary care setting. | PMC10664149 | ||
Method | LRTI | Children aged 6 months to 12 years presenting with uncomplicated LRTI were included in the cohort. Children were randomised to receive amoxicillin 50 mg/kg per day for 7 days or placebo, or if not randomised they participated in a parallel observational study to maximise generalisability. Baseline clinical data were us... | PMC10664149 | |
Results | A total of 758 children participated ( | PMC10664149 | ||
Conclusion | LRTI | A simple three-item prognostic score could be useful as a tool to identify children with LRTI who are at low risk of an adverse outcome and to guide clinical management. | PMC10664149 | |
INTRODUCTION | fits, LRTI | LOWER RESPIRATORY TRACT INFECTION, LRTI, COMPLICATION | Lower respiratory tract infection (LRTI) is a frequent trigger for attendance in primary care, where nearly all children are managed, most receiving antibiotics.Judicious and targeted use of antibiotics is likely to be key to both efficient clinical care and minimising the risk of antibiotic resistance. Clinicians are ... | PMC10664149 |
METHOD | PMC10664149 |
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